Human Subjects Research - Institutional Review Boards - IRBs

IRB Quick Links

Does the Project Require IRB Review and Approval?

You need to answer the following three questions to determine if your
project requires IRB review and approval. Determination forms are located
on our forms
library.

1. Is UVM or UVM Medical Center engaged in the activity?

2. Is the activity in which you will be engaged RESEARCH?

3. Will the activity involve HUMAN SUBJECTS?

1. Engagement

An individual is considered engaged in human research when he/she for
the purposes of the nonexempt research project, obtains: (1) data about the
subjects of the research through intervention or interaction with them; (2)
identifiable private information about the subjects of the research; or (3) the
informed consent of human subjects for the research. An institution is
considered engaged when its employees or agents conduct the above activities,
or when the institution receives a direct federal award to conduct human
subject research, even when all activities involving human subjects are carried
out by a subcontractor.

The following two flows will assist you in making the next determinations.

3. Will the activity involve HUMAN SUBJECTS?

Certain types of
applications may involve human subjects
(within the funding period) but definite plans are not included in the
application or protocol. This type of application would
include such activities as institutional grants, training grants, and
projects in which human subjects' involvement will depend upon
completion of instruments, prior animal studies, or purification of
compounds. The IRB must certify that all human subjects research
contained within a grant application has been reviewed and approved
prior to release of funds, even if the plans for human subject
involvement is unknown. Therefore, investigators should
submit the Initial Administrative Review of an Umbrella Grant or
Projects to be Developed form. This will allow the IRB to
certify what is in the grant with the caviat that not all activities
specific to human subject involvement have been reviewed.
This will allow the release of grant funds so that work may
begin.

However, no human subjects
may be involved until a human
subjects
protocol has been reviewed and approved by the Committee.
This new certification would be the approval of record going forward
and you may be required to obtain prior approval or submit the new
certificate to the funder.